LEWISBERRY, Pa., Sept. 1 /PRNewswire-FirstCall/ — Unilife
Corporation (“Unilife” or “Company”) (Nasdaq: UNIS, ASX: UNS),
today announced that its Unitract™ Tuberculin (TB) Syringe
has received 510(k) market clearance from the U.S. Food and
Drug Administration (FDA).
The Unitract™ TB syringe is a variant of the
Unitract™ 1mL Insulin Syringe for which Unilife secured FDA
clearance earlier this year. Unlike insulin syringes which are
primarily used by people with diabetes, TB syringes are used for
the administration of a range of therapeutic drugs and vaccines
within acute-care hospitals and other healthcare facilities.
The Unitract™ range of 1mL syringes is the world’s first
and only known syringe that allows operators to control the speed
of passive (automatic) needle retraction directly from the
patient’s body into the barrel of the syringe where it is locked in
place. The products are well positioned to help prevent the
transmission of blood-borne diseases such as HIV and hepatitis C
via needlestick injuries, aerosol dispersal and syringe reuse.
Primary target markets of the products include healthcare
facilities, pharmaceutical companies and patients who
self-administer prescription medication. Production of the
Unitract™ 1mL syringe is occurring at Unilife’s
FDA-registered manufacturing facility in Lewisberry,
Pennsylvania.
Mr. Alan Shortall, Chief Executive Officer of Unilife, stated,
“U.S. FDA 510k market clearance for our Unitract™ TB syringe
marks an important step in our company’s efforts to bring a
complete line of safety syringes to market, as it is our second
product to receive this clearance. With TB syringes most
commonly used within acute-care hospitals and other healthcare
facilities, FDA clearance of our Unitract™ TB syringe
significantly broadens our capacity to market our unique products
across the U.S. and other key international markets.”
Unilife has als
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